DuoFLEX® Coil Suite - The 10cm Right Coil Assembly is a part of the - M R Instruments, Inc.

Duns Number:112719096

Device Description: The 10cm Right Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC The 10cm Right Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 1520G-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 4 or 8 channels for imaging.

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More Product Details

Catalog Number

40-00300-002

Brand Name

DuoFLEX® Coil Suite

Version/Model Number

FC1520G-8R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173290

Product Code Details

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Device Record Status

Public Device Record Key

0e21fb34-1c9a-436b-aebe-3101bf73b384

Public Version Date

March 18, 2022

Public Version Number

1

DI Record Publish Date

March 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"M R INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22